Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis
Intervention: Darapladib (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This is a study to assess the effects of darapladib on the cardiac conduction of the heart as
compared to placebo and moxifloxacin. This a four period crossover design with each period
lasting about 10 days. There will be a 7 to 10 day wash out in between each period.
Clinical Details
Official title: A Study to Evaluate the Effect of Repeat Oral Doses of Darapladib on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Change in QTc interval as compared to placebo and moxifloxacin
Secondary outcome: Change in ECG parameters as compared to placebo and moxifloxacin
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy
- Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
- Signed and dated written informed consent prior to admission to the study
- Subject is able to understand and comply with protocol requirements, instructions and
protocol-stated restrictions
Exclusion Criteria:
- cardiac abnormalities
- history of asthma or severe allergic reactions
- history of alcohol or drug abuse
- use of prescription or non-prescription drugs or vitamins or herbal supplements
- history of cholecystectomy or biliary tract disease
- pregnant or nursing women
- history of allergy to the study drugs
Locations and Contacts
GSK Clinical Trials Call Center, Evansville, Indiana 47714, United States
Additional Information
Starting date: December 2006
Last updated: September 4, 2007
|
